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Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

Information source: Bial - Portela C S.A.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: BIA 2-093 (Drug); Oxcarbazepine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bial - Portela C S.A.

Official(s) and/or principal investigator(s):
Manuel Vaz-da-Silva, MD, PhD, Principal Investigator, Affiliation: BIAL - Portela & Cª S.A

Summary

To investigate the pharmacokinetics of a single 900 mg oral dose of BIA 2-093 and a single 900 mg oral dose of Oxcarbazepine in healthy volunteers and to assess the tolerability of a single 900 mg dose of BIA 2-093 and Oxcarbazepine.

Clinical Details

Official title: Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum Drug Concentration (Cmax)

Secondary outcome: Area Under the Plasma Concentration Versus Time Curve (AUC)

Detailed description: Single centre, open label, balanced randomised, two-way crossover study in 12 healthy volunteers. The study consisted of 2 periods separated by a washout period of 7 days or more. On each of the study periods the volunteers received either a single 900 mg oral dose of BIA 2-093 or a single 900 mg oral dose of Oxcarbazepine.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female subjects aged between 18 and 45 years, inclusive.

- Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.

- Subjects who were healthy as determined by pre-study medical history, physical

examination, neurological examination, and 12-lead ECG.

- Subjects who had clinical laboratory tests acceptable.

- Subjects who were negative for HBs Ag, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at

screening.

- Subjects who were negative for alcohol and drugs of abuse at screening and admission.

- Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per

day.

- Subjects who were able and willing to give written informed consent.

- In case of female volunteers, subjects who were not of childbearing potential by

reason of surgery or, if of childbearing potential, used one of the following methods of contraception: double-barrier, intrauterine device or abstinence.

- In case of female volunteers, subjects who had a negative pregnancy test at screening

and admission Exclusion Criteria:

- Subjects who did not conform to the above inclusion criteria.

- Subjects who had a clinically relevant history or presence of respiratory,

gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.

- Subjects who had a clinically relevant surgical history.

- Subjects who had a clinically relevant family history.

- Subjects who had a history of relevant atopy.

- Subjects who had a history of relevant drug hypersensitivity.

- Subjects who had a history of alcoholism or drug abuse.

- Subjects who consumed more than 21 units of alcohol a week.

- Subjects who had a significant infection or known inflammatory process on screening

and/or admission.

- Subjects who had acute gastrointestinal symptoms at the time of screening and/or

admission (e. g., nausea, vomiting, diarrhoea, heartburn).

- Subjects who had used prescription drugs within 4 weeks of first dosing.

- Subjects who had used over-the-counter medication excluding oral routine vitamins but

including mega dose vitamin therapy within one week of first dosing.

- Subjects who had used any investigational drug and/or participated in any clinical

trial within 2 months of their first admission.

- Subjects who had previously received BIA 2-093.

- Subjects who had donated and/or received any blood or blood products within the

previous 2 months prior to screening.

- Subjects who were vegetarians, vegans and/or had medical dietary restrictions.

- Subjects who could not communicate reliably with the investigator.

- Subjects who were unlikely to co-operate with the requirements of the study.

- Subjects who were unwilling or unable to give written informed consent.

- In case of female volunteers, subjects who were pregnant or breast-feeding.

- In case of female volunteers, subjects who were of childbearing potential and did not

use an approved effective contraceptive method or used oral contraceptives.

Locations and Contacts

BIAL - Portela & Cª - Human Pharmacology Unit (UFH), S. Mamede do Coronado, Trofa 4745-457, Portugal
Additional Information

Starting date: March 2002
Last updated: December 19, 2014

Page last updated: August 23, 2015

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